SynCardia Total Artificial Heart: A17-Year Single-Center Experience with 187 Patients

Objectives: The SynCardia (formerly CardioWest) total artificial heart (TAH) is a pneumatically driven assist device to provide mechanical circulatory support in patients with severe nonreversible biventricular failure. In this retrospective single-center study, we sought to determine short- and long-term outcomes in patients undergoing TAH implantation.

Methods: Between February 2001 and December 2018, a total of 187 consecutive patients (mean age, 53 ± 12 years, 89% males) underwent TAH implantation. Time-to-event analysis with Kaplan–Meier estimator was used to determine survival function. Multivariate analysis was used to determine predictors for mortality.

Results: Indications for TAH implantation were cardiomyopathy in 83 (44.4%), acute myocardial infarction in 49 (26.2%) and postcardiotomy biventricular heart failure in 29 (15.5%) and others (allograft rejection, myocarditis, endocarditis, and congenital heart disease) in 26 patients (13.9%). One hundred and twenty-three patients (65.8%) had previous cardiac surgery. Preimplant, the majority of patients (163/87.2%) were in INTERMACS profile 1, the remainder (24/12.8%) in INTERMACS profiles 2 and 3.

The median support time was 171 days (range, 1 to 971 days, 2.7 years). During TAH support, 32.6% of patients suffered from stroke, 30.6% from mesenteric ischemia and 24.7% from gastrointestinal bleeding. The 1-, 6-, and 12-month survival was 71, 42, and 35%, respectively. A total of 118 (63.1%) patients died during support. The most common causes of the death were multiorgan failure and sepsis. Multivariate analysis revealed that age (HR = 1.032; 95% CI: 1.011–1.054, p = 0.003), BMI < 18.5 kg/m² (HR = 4.467; 95% CI: 1.882-10.947; p = 0.001), higher total bilirubin (HR = 1.066; 95% CI: 1.017–1.118, p = 0.007) and preoperative IABP (HR = 0.576; 95% CI: 0.375–0.885, p = 0.012) were independent predictors for mortality during support.

Sixty-nine (36.9%) were successfully bridged to transplantation after a mean support time of 309 ± 203 days. 1-, 5-, and 10-year survival was 64, 58, and 51%, respectively.

Conclusion: SynCardia TAH provides acceptable outcomes in critically ill patients with terminally heart failure who otherwise have only very limited or no treatment options. A considerable proportion of TAH patients can be successfully bridged to transplantation. Independent predictors of mortality may be used to risk stratify patients in order to further refine patient selection.